Efficacy and Safety of Folisurge - a Biosimilar Recombinant Follicle-Stimulating Hormone - Versus Gonal-f in Assisted Reproductive Technology Practice in India: A Real-World Study

Q: What was the main objective of the study?

To compare the efficacy and safety of Folisurge versus Gonal-f in assisted reproductive technology patients.

Q: How was the study designed and who was included?

It was a non-interventional, investigator-initiated, real-world retrospective study including women aged 21–40 with BMI 17–34.9 and serum AMH >1.2 ng/mL receiving Folisurge or Gonal-f during controlled ovarian stimulation.

Sep 29, 2026

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Objective: Compare efficacy and safety of Folisurge, a biosimilar recombinant follicle-stimulating hormone (r-FSH), versus Gonal-f, an innovator r-FSH, in patients undergoing assisted reproductive technology (ART). Methods: Retrospective real-world study in women aged 21-40 with BMI 17-34.9, AMH >1.2 ng/mL, receiving Folisurge or Gonal-f during controlled ovarian stimulation (COS). Primary endpoint: mean metaphase II (MII) oocytes retrieved; secondary endpoints included embryos formed and β-hCG positive rate. Results: 3090 women analyzed (1210 vs 1880). Higher AFC and yields of oocytes, MII oocytes, and embryos with Folisurge; β-hCG positive rate similar; no major safety concerns. Conclusion: Comparable effectiveness with safety; interpretation of higher yields considers baseline AFC differences.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

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Abstract

Objective

Methods

Results

Conclusion

Introduction

Review began 10/29/2025 Review ended 11/28/2025 Published 12/07/2025 © Copyright 2025 Sanagoudar et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CCBY 4.0. , which permits unrestricted use , distribution , and reproduction in any medium , provided the original author and source are credited. DOI: 10.7759/cureus.98622 Open Access Original Article Efficacy and Safety of Folisurge, a Biosimilar Recombinant Follicle-Stimulating Hormone, Versus Gonal-F in Assisted Reproductive Technology Practice in India: A Real-World Study Shashank Sanagoudar 1, Vipin Chandra 2, Shipra Nigam 3, Anjali Gahalan 4, Ritu Punhani 5 , Nihita Pandey Sara Zaidi 7, Jyoti Panday 8, Nihar Ranjan Bhoi 1, Walmik Mistari 9, Isha Suwalka 10, Nitasha Gupta 1 6 , 1. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Udaipur, IND 2. Department of Clinical Research and Operations, Indira IVF Hospital Private Limited, Udaipur, IND 3. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Shahdara, IND 4. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Allahabad, IND 5. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, New Delhi, IND 6. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Kolkata, IND 7. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Dadar, IND 8. Department of Reproductive Medicine, Indira IVF Hospital Private Limited, Ghaziabad, IND 9. Department of Clinical Lab and Operations, Indira IVF Hospital Private Limited, Udaipur, IND 10. Department of Research and Publication, Indira IVF Hospital Private Limited, Udaipur, IND Corresponding author: Shashank Sanagoudar, [drsanagoudar@gmail.com](drsanagoudar@gmail.com) Abstract Objective: This study was conducted to compare the efficacy and safety of Folisurge, a biosimilar recombinant follicle-stimulating hormone (r-FSH), with Gonal-f, an innovator r-FSH, in patients undergoing assisted reproductive technology (ART) . Methods: In this non-interventional, investigator-initiated, real-world, retrospective study, females aged 21-40 years with a body mass index (BMI) ranging between 17 and 34 .9 kg/m2, with serum anti-Müllerian hormone (AMH) more than 1.2 ng/mL, undergoing controlled ovarian stimulation (COS), and those having received Folisurge or Gonal-f were included. The primary outcome was the mean number of metaphase II (MII) oocytes retrieved in each group. Secondary outcomes included the mean number of embryos formed and serum β-human chorionic gonadotropin (β-hCG) positive rate in each group. Results: A total of 3090 women were included, out of which 1210 and 1880 received Folisurge and Gonal-f, respectively. The baseline demographics were comparable in the two groups. The mean antral follicle count (AFC) was significantly higher in the Folisurge vs. the Gonal-f group (23 .8 vs. 20.6, p < 0 .001) . Also, the mean (SD) number of oocytes retrieved was significantly higher in the Folisurge vs. the Gonal-f group (18 .1 (9 .4) vs. 15.5 (8 .3), p < 0 .001) . The mean (SD) number of MII oocytes retrieved with Folisurge was significantly higher than Gonal-f (13 (7.5) vs. 10.9 (6 .6), p < 0 .001) . Also, the mean (SD) number of embryos formed was also higher in the Folisurge vs. the Gonal-f group (4 .9 (4 . 1) vs. 4.7 (4 . 1), p = 0 .022) . The serum β-hCG positive rate was similar between the two groups (75 .5% vs. 76.2%, p = 0 .667) . No major safety concerns were observed in the study. Conclusion: Folisurge was comparable to Gonal-f in terms of serum β-hCG positive rate. The higher yield ofoocytes and embryos in the Folisurge group should be interpreted in the context of its higher baseline AFC, which may have influenced these results. No major safety concerns were observed. Categories: Other, Obstetrics/Gynecology, Healthcare Technology Keywords: antral follicle count (a

FAQs

What was the main objective of the study?

To compare the efficacy and safety of Folisurge versus Gonal-f in assisted reproductive technology patients.

How was the study designed and who was included?

It was a non-interventional, investigator-initiated, real-world retrospective study including women aged 21–40 with BMI 17–34.9 and serum AMH >1.2 ng/mL receiving Folisurge or Gonal-f during controlled ovarian stimulation.

What outcomes were used to evaluate efficacy and what were the safety findings?

Primary efficacy was mean metaphase II (MII) oocytes retrieved; secondary outcomes included embryos formed and serum β-hCG positive rate. No major safety concerns were observed, and β-hCG positive rates were similar between groups.

Sep 29, 2026

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